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Preparation for the Prevention And/Or Treatment of Dementia Syndromes

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Preparation for the Prevention And/Or Treatment of Dementia Syndromes (19) & (11) EP 2 070 519 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 17.06.2009 Bulletin 2009/25 A61K 9/107 (2006.01) A61P 25/28 (2006.01) A23L 1/302 (2006.01) A23J 7/00 (2006.01) (2006.01) (21) Application number: 09156648.9 A23L 1/304 (22) Date of filing: 08.05.2001 (84) Designated Contracting States: (72) Inventors: AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU • Kiliaan, Amanda, Johanne MC NL PT SE TR 6706 AS WAGENINGEN (NL) • Hageman, Robert Johan Joseph (30) Priority: 08.05.2000 US 566386 6705 CT Wageningen (NL) 02.11.2000 US 703798 (74) Representative: Swinkels, Bart Willem (62) Document number(s) of the earlier application(s) in Nederlandsch Octrooibureau accordance with Art. 76 EPC: J. W. Frisolaan 13 07120681.7 / 1 911 442 2517 JS Den Haag (NL) 01928256.5 / 1 282 365 Remarks: (71) Applicant: N.V. Nutricia This application was filed on 30-03-2009 as a 2712 HM Zoetermeer (NL) divisional application to the application mentioned under INID code 62. (54) Preparation for the prevention and/or treatment of dementia syndromes (57) The present invention relates to a preparation phatidylcholine and phosphatidylethanolamine. suitable for the prevention and/or treatment of vascular fraction c) compounds which are a factor in methionine disorders, comprising the following fractions: metabolism, which fraction contains at least one member fraction a) long chain polyunsaturated fatty acids; selected from the group consisting of folic acid, vitamin fraction b) phospholipids, which fraction contains at least B12, vitamin B6, magnesium and zinc. two different phospholipids selected from the group con- sisting ofphosphatidylserine, phosphatidylinositol, phos- EP 2 070 519 A1 Printed by Jouve, 75001 PARIS (FR) EP 2 070 519 A1 Description Background of the invention 5 [0001] The present invention relates to preparations suitable for the prevention and/or treatment of vascular disorders. The invention also relates to the use of these preparations for the prevention and/or treatment of diseases that find their main cause in vascular problems, in particular dementia syndromes. [0002] The vascular system in the human body is well described in the art. An important part of the system are the blood vessels, that generally are divided in arteries and veins, dependent whether they transport blood to or from the 10 heart. They vary in size from large (e.g. the aorta) to very small (capillaries). From an anatomical point of view larger blood vessels in general comprise as observed from the lumen side: 1. the tunica intima, that consists of a smooth (mono)layer of endothelial cells and a subendothelial layer that consists of a loose layer of connective tissue, 15 2. the tunica media, which consists of a layer of (innervated) smooth muscle cells and elastic fibers, and 3. the tunica adventitia which is composed of loosely woven collagen fibers, which are infiltrated by tiny lymphatic and blood vessels. [0003] The endothelial cells in the tunica intima are in direct contact with blood and have a barrier function for the 20 underlying tissue. This barrier function includes selective transport of components from blood to the underlying tissue and vice versa, and protection of the underlying tissue. Endothelial cells get easily damaged due to a wide variety of causes like mechanic forces or interaction with stressor components such as classic anaphylatoxins, and components that may occur in the blood, such as homocysteine or components that result from treatment with certain types of drugs (e.g. chemotherapeutics). Vascular permeability can further be increased by a wide variety of humoral- and cell-derived 25 mediators. [0004] Endothelial dysfunction can result in a wide range of disorders. Damage to the endothelial layer can disturb the physiological functions thereof such as transport properties and expose the underlying tissue to stressors. Monocytes may migrate to these damaged spots, get caught by adhesion molecules, differentiate into macrophages, which, when activated, may start up an inflammatory reaction. Due to this reaction cytokines may be released, which may trigger the 30 release of reactive oxygen species, or change coagulation behaviour of blood components. This may result in occurrence of plaques in the arteries, which may ultimately result in hypertension, atherosclerosis and (later) arteriosclerosis. [0005] Atherosclerosis may lead to an impaired blood supply to tissue, which may then become ischaemic. This may lead to damage to cells and even apoptose of the cells that depend on the oxygen and nutrient supply via these blood vessels. Tissue that has become ischaemic may thus lose functional capacity. 35 [0006] Dementia syndromes are characterised by an abnormal high and progressive loss of functional capacity of the brain. This process may start relatively early in life, like the dementias that are associated with some forms of epileptics, encephalitis, Huntington’s disease, the dementias that can be observed after intoxication by (chronic) alcohol or drug abuse and the dementias due to cerebrovascular accidents and some genetic forms of dementias (early onset dementias). It may also start relatively late in life such as in Alzheimer’s disease (presenile dementia), in senile dementia and in 40 atherosclerotic dementia. Dementias may develop suddenly, e.g. after an apoplectic event, or develop very slowly such as in senile dementia. [0007] Alzheimer’s disease is characterised by an early step of excision of the amyloid-beta peptide (AB) from the precursor protein (APP) that is present in the endosomes of neurons or other cells of the central nervous system. The AB peptide produced by beta-secretase (BACE) may diffuse outside the cell and polymerise into amyloid filaments, 45 which in turn may develop into mature amyloid plaques, especially when chaperone molecules like protease inhibitors are present. The inflammatory response to the deposits of AB polymers and/or amyloid plaque may eventually lead to neuronal cell death and loss of cerebral function. [0008] Dementia syndromes occur relatively frequently; about 10 % of the elderly population in the Netherlands suffer from this disease and still no cure has been found to prevent or treat dementias. Treatment with drugs that increase 50 brain levels of neurotransmitters like acetylcholine, serotonin or (nor)adrenaline are ineffective in the long term and the relatively high doses that often are administered could lead to undesirable side effects. [0009] For the prevention and treatment of vascular disorders no suitable therapy is available either. Vascular disorders and the consequences thereof are a major cause of death in the Western countries. At present vascular disorders are treated by prescribing specific diets that are restricted in cholesterol, saturated fatty acids and in some cases sodium 55 content and by administering drugs that are designed to lower blood pressure (e.g. diuretics), and plasma levels of cholesterol e.g. statins (or other compounds that are able to inhibit the activity ofHMG-CoA reductase). [0010] Though some of the treatments are indeed effective in treating part of the phenomena associated with vascular problems, the treatments are not 100% effective in solving the real problem (the cause) and they may demonstrate 2 EP 2 070 519 A1 undesired systemic side effects. Prior art 5 [0011] Vascular endothelial cells and their function in the blood vessel have been studied for a long time. Many details about biochemical processes that occur in these cells have been published as well. [0012] Recently Chang published in vitro data about the effect of pyridoxal-5-phosphate on human umbilical vein endothelial cells that "suggested that vitamin B6 protects endothelial cells by enhancing the beneficial function and preventing cell injury which are responsible for the initiation and the disease process of atherosclerosis". See Chang 10 S.J. Nutrition Research, 1999, 19 (11), 1613-1624; "Vitamin B6 protects vascular endothelial injury by activated platelets". [0013] Much literature has appeared about the aetiology of vascular diseases and dementia syndromes. Associations have been made between consumption of fruit on plasma levels of homocysteine or cholesterol and the presence of cardiovascular diseases. [0014] The structure of cell membranes has been studied; many different components appear to be part of the mem- 15 brane, such as lipids, proteins and cholesterol. Cholesterol appears to be important for the cell membrane. It decreases the fluidity of the outer cell membrane. It also is able to capture some radicals and is claimed to stop self-propagating radical chain reactions in the cell membrane. It is currently thought that vascular disorders should be treated with cholesterol lowering diets. However, it is not recognised that cholesterol, in particular plasma cholesterol, could be important in the repair mechanisms associated with vascular damage. 20 [0015] WO 99/11625 discloses the use of specific derivatives of huperzine A for inhibiting acetylcholine esterase for example in the treatment of Alzheimer’s dementia and myasthemia gravis. [0016] EP 0213724 discloses the use of phosphatidylcholine and phosphatidylethanolamine for membrane fluidisation. [0017] Citric acid and/or citrates are widely used in food manufacture as taste modifier, acidifier and product stabiliser. US 5,234,702 and 5,077,069 disclose the use of citric acid as a synergetic component for the antioxidant action of 25 ascorbyl palmitate, beta-carotene
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